Alglucosidase Alfa use while Breastfeeding

Alglucosidase Alfa Levels and Effects while Breastfeeding

Summary of Use during Lactation

Because alglucosidase is a large protein molecule with a molecular weight of about 110,000, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract Alglucosidase alfa activity was detectable in breastmilk for only 24 hours after a dose in one woman. The investigators recommended withholding breastfeeding for 24 hours after each dose as a precaution until more data are obtained.[1]

Drug Levels

Maternal Levels. One 40-year-old woman with adult-onset Pompe disease received alglucosidase alfa during pregnancy and lactation in an intravenous dose of 20 mg/kg every 2 weeks. The alglucosidase activity in breastmilk before the injection was 3 nmol/hour.ml, Which was about 10% of what the authors had measured in the milk of an unaffected woman. Breastmilk activity peaked 2.5 hours after the end of the infusion at 245 nmol/h.mL which was 0.3% of the peak plasma value. Direct measurement of alglucosidase alfa in the breastmilk of the normal mother and the mother receiving the drug were consistent with these activity measurements. Alglucosidase alfa was undetectable (assay limit not stated) 24 hours after the end of the infusion.[1]

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

An infant was born to a mother receiving alglucosidase alfa during pregnancy and lactation in an intravenous dose of 20 mg/kg every 2 weeks for adult-onset Pompe disease. At 3 and 77 days of age, the infant's serum had negligible anti-alglucosidase alfa antibodies. The infant was examined regularly up to 1 year of age and showed normal development, although the extent of breastfeeding during this time was not stated.[1]

References

Alglucosidase Alfa Identification

Substance Name

Alglucosidase Alfa

CAS Registry Number

420784-05-0

Drug Class

Breast Feeding

Lactation

Enzymes

Enzyme Replacement Therapy

Administrative Information

LactMed Record Number

907

Disclaimer

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